Media

Article – FDA Braces for Looming Boom in Cell and Gene Therapy Submissions
Published By: BioSpace
Date: June 12, 2023
Author: Ana Mulero (BioSpace), with contributions from Greg Meyer and Kenneth Ndugga-Kabuye
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Article – US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development
Published By: Drug Discovery Today
Date: May 15, 2023
Authors: William Salminen, Olu Aloba, Angela Drew, Agnieszka Marcinowicz, and Madelyn Huang
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Press Release – Premier Research Fortifies Cell and Gene Therapy Leadership Team, Strengthening End-to-End Capabilities in Complex Asset Development
Published By: Premier Research
Date: April 17, 2023
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Press Release – Premier Research and InSilicoTrials Partner to Leverage In Silico Modeling and Simulation and Optimize Regulatory Pathways for Rare Disease Therapies
Published By: Premier Research
Date: March 13, 2023
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Article – Update on FDA regulation of ophthalmic combination products
Published By: Regulatory Focus
Date: January 31, 2023
Authors: Olu Aloba, Marianthi Karakatsani, and Laura Kilgore
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Press Release – Premier Research and CENTOGENE Launch Strategic Partnership to Accelerate and De-Risk Rare Disease Clinical Development
Published By: Premier Research
Date: January 9, 2023
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News Release – Premier Consulting Expands Team in Global Regulatory Affairs
Published By: Premier Consulting
Date: November 7, 2022
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Article – Nitrosamines in pharmaceuticals: Scientific and regulatory status
Published By: Regulatory Focus
Date: August 31, 2022
Authors: Olu Aloba and Marianthi Karakatsani
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News Release – Premier Research Launches Premier Consulting Business Unit, Creating Unified Regulatory and Strategic Product Development Brand
Published By: Premier Consulting
Date: February 22, 2022
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